Liver Cancer Clinical Trial
Official title:
A Phase I/II Trial Testing Immunization With AFP + GM-CSF Plasmid Prime And AFP Adenoviral Vector Boost In Patients With Hepatocellular Carcinoma (AFP Prime-Boost Protocol)
RATIONALE: Vaccines made from DNA and a gene-modified virus may make the body build an
immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune
response and prevent or delay the recurrence of liver cancer.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy
and to see how well it works in treating patients with stage II, stage IIIA, stage IIIB, or
stage IVA liver cancer.
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of adjuvant vaccination
comprising alpha fetoprotein (AFP) plasmid DNA and sargramostim (GM-CSF) plasmid DNA
followed by AFP adenoviral vector boost in patients with HLA-A*0201-expressing stage
II-IVA hepatocellular carcinoma.
Secondary
- Determine the optimal biological dose of this regimen, as defined by the generation of
AFP-specific immunity, in these patients.
- Determine disease-free survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of alpha fetoprotein (AFP) adenoviral vector boost.
Patients receive vaccination comprising AFP plasmid DNA and sargramostim (GM-CSF) plasmid
DNA intramuscularly (IM) on days 1, 30, and 60 in the absence of unacceptable toxicity.
Patients then receive boost immunization comprising AFP adenoviral vector IM and
intradermally on day 90.
Cohorts of 3-6 patients receive escalating doses of AFP adenoviral vector boost until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 3 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.
;
Primary Purpose: Treatment
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